{"id":391,"date":"2023-09-06T09:08:23","date_gmt":"2023-09-06T13:08:23","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=391"},"modified":"2023-09-06T09:08:23","modified_gmt":"2023-09-06T13:08:23","slug":"fdas-second-warning-letter-of-the-year-deals-with-potentially-misleading-efficacy-claims-about-inhaler","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/09\/06\/fdas-second-warning-letter-of-the-year-deals-with-potentially-misleading-efficacy-claims-about-inhaler\/","title":{"rendered":"FDA&#8217;s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler"},"content":{"rendered":"<p>On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a\u00a0<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/astrazeneca-pharmaceuticals-lp-664789-08042023\" target=\"_blank\" rel=\"noopener\">warning letter<\/a>\u00a0to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure\u00a0for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug\u2019s efficacy.<\/p>\n<p>In view of the warning letter\u2014only the second of the year issued by the Office of Prescription Drug Promotion (OPDP)\u2014companies should review their promotional materials to confirm that any efficacy claims are clearly supported by cited data and do not give rise to misleading impressions and regulatory scrutiny\u2014even where such materials are intended for patients.<\/p>\n<p>Read the full\u00a0<em>Alert<\/em> on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_second_warning_letter_2023_over_potentially_misleading_efficacy_claims_0823.html\">Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a\u00a0warning letter\u00a0to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure\u00a0for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug\u2019s efficacy. In view of the warning letter\u2014only the second of the year issued by &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/09\/06\/fdas-second-warning-letter-of-the-year-deals-with-potentially-misleading-efficacy-claims-about-inhaler\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[664,29,209,663,639,298,172],"ppma_author":[521],"class_list":["post-391","post","type-post","status-publish","format-standard","hentry","category-general","tag-efficacy-claims","tag-fda","tag-frederick-ball","tag-inhaler","tag-kelly-bonner","tag-patrick-gallagher","tag-warning-letter"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/391","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=391"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/391\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=391"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=391"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=391"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=391"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}